The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

Surgical Site Infection Clinical Trial

Official title:

The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902419
• Other study ID #: AlbanyMC2984
• Status: Completed
• Phase: N/A
• First received: September 12, 2016
• Last updated: September 14, 2016
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2016
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial measuring surgical site infection rate as a function of timing of wound dressing removal.

Description:

A randomized controlled trial with a sample size of 602 patients to study the effect of timing of wound dressing removal on the surgical site infection rate. 300 patients were randomized to a group that had the wound dressing removed between 12-30 hours postoperatively. 302 patients were randomized to a group that had the wound dressing removal between 30-48 hours postoperatively. Statistical analyses were performed to determine if the timing of dressing removal had statistical significance on the surgical site infection rate, the primary outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• patients ages 18-50 years;

• medically competent (no proxies or prisoners); and

• multifetal and singleton gestations from 23 0/7 weeks to 42 0/7 weeks gestational age.

Exclusion Criteria:

• Inability to obtain informed consent;

• fetal death;

• immunocompromised patients; patients taking immuno-suppressants; history of documented surgical site infection; or patients requiring reoperation within the 6 week postoperative period for indications other than wound dehiscence/debridement/infection.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• Wound dressing removal.

Locations

Country	Name	City	State
United States	St. Peter's Hospital	Albany	New York
United States	Bellevue Women's Center	Niskayuna	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (13)

Anderson DJ, Podgorny K, Berríos-Torres SI, Bratzler DW, Dellinger EP, Greene L, Nyquist AC, Saiman L, Yokoe DS, Maragakis LL, Kaye KS. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27. doi: 10.1086/676022. — View Citation

Chen WY, Rogers AA, Lydon MJ. Characterization of biologic properties of wound fluid collected during early stages of wound healing. J Invest Dermatol. 1992 Nov;99(5):559-64. — View Citation

Consensus paper on the surveillance of surgical wound infections. The Society for Hospital Epidemiology of America; The Association for Practitioners in Infection Control; The Centers for Disease Control; The Surgical Infection Society. Infect Control Hosp Epidemiol. 1992 Oct;13(10):599-605. Review. — View Citation

Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: http://10.1097/AOG.0b013e31827a072c. Erratum in: Obstet Gynecol. 2013 May;121(5):1113. — View Citation

Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Kirmeyer S, Mathews TJ, Wilson EC. Births: final data for 2009. Natl Vital Stat Rep. 2011 Nov 3;60(1):1-70. — View Citation

Olsen MA, Butler AM, Willers DM, Devkota P, Gross GA, Fraser VJ. Risk factors for surgical site infection after low transverse cesarean section. Infect Control Hosp Epidemiol. 2008 Jun;29(6):477-84; discussion 485-6. doi: 10.1086/587810. — View Citation

Ovington LG. Hanging wet-to-dry dressings out to dry. Home Healthc Nurse. 2001 Aug;19(8):477-83; quiz 484. — View Citation

Owen J, Andrews WW. Wound complications after cesarean sections. Clin Obstet Gynecol. 1994 Dec;37(4):842-55. Review. — View Citation

Pavlidis TE, Galatianos IN, Papaziogas BT, Lazaridis CN, Atmatzidis KS, Makris JG, Papaziogas TB. Complete dehiscence of the abdominal wound and incriminating factors. Eur J Surg. 2001 May;167(5):351-4; discussion 355. — View Citation

Poulsen KB, Bremmelgaard A, Sørensen AI, Raahave D, Petersen JV. Estimated costs of postoperative wound infections. A case-control study of marginal hospital and social security costs. Epidemiol Infect. 1994 Oct;113(2):283-95. — View Citation

Toon CD, Ramamoorthy R, Davidson BR, Gurusamy KS. Early versus delayed dressing removal after primary closure of clean and clean-contaminated surgical wounds. Cochrane Database Syst Rev. 2013 Sep 5;(9):CD010259. doi: 10.1002/14651858.CD010259.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;(9):CD010259. — View Citation

Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2011 Mar;117(3):682-90. doi: 10.1097/AOG.0b013e31820ad61e. Review. Erratum in: Obstet Gynecol. 2011 Jun;117(6):1440. — View Citation

van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site infection Rate	Cellulitis, purulent drainage, abscess or wound requiring drainage, debridement, and antibiotics associated with a clinical diagnosis of infection. Any disruption of fascia or subcutaneous skin.	6 weeks postoperatively	No